stay away from Rynatan Chewable Pediatric Tablets Generic Name: phenylephrine tannate and chlorpheniramine tannate Dosage Form: chewable tablet Side Effects Dosage Professional Interactions Pregnancy More User Reviews Drug Images Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. RYNATAN Chewable Pediatric Tablets IN-0712-05 Rev. 1/09 Description Rynatan Chewable Pediatric Tablets are an antihistamine/nasal decongestant combination. Each grape flavored chewable tablet contains: Phenylephrine Tannate 5 mg Chlorpheniramine Tannate 4.5 mg Other ingredients: FD&C Blue No. 2, FD&C Red No. 40, flavor (artificial), magnesium stearate, maltodextrin, saccharin sodium, sodium starch glycolate, sucrose, talc. Slideshow OTC Medication Use In Pregnancy: Wise or Worrisome? Clinical Pharmacology Rynatan Chewable Pediatric Tablets combine the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of chlorpheniramine. Indications and Usage Rynatan Chewable Pediatric Tablets are indicated for symptomatic relief of the coryza and nasal congestion associated with the common cold, sinusitis, allergic rhinitis and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease. Contraindications Rynatan Chewable Pediatric Tablets are contraindicated for newborns, nursing mothers and patients sensitive to any of the ingredients or related compounds. Warnings Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow angle glaucoma or prostatic hypertrophy. Use with caution or avoid use in patients taking monoamine oxidase (MAO) inhibitors, or within 14 days of stopping such treatment. This product contains an antihistamine which may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Precautions General: Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients. Antihistamines may cause excitation, particularly in children, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Information for patients: Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson s disease), or for 2 weeks after stopping the MAOI drug. If patients are uncertain whether a prescription drug contains an MAOI, they should be instructed to consult a health professional before taking such a product. Drug interactions: MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents. Carcinogenesis, mutagenesis, impairment of fertility: No long term animal studies have been performed with Rynatan Chewable Pediatric Tablets. Pregnancy: Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Rynatan Chewable Pediatric Tablets. It is also not known whether Rynatan Chewable Pediatric Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rynatan Chewable Pediatric Tablets should be given to a pregnant woman only if clearly needed. Nursing mothers: Rynatan Chewable Pediatric Tablets should not be administered to a nursing woman. Adverse Reactions To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Adverse effects associated with the Rynatan Chewable Pediatric Tablets antihistamine and sympathomimetic ingredients at recommended doses have been minimal. The most common have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare. Overdosage Signs & symptoms: May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent. Treatment: Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered. Dosage and Administration Administer the recommended dose every 12 hours. Rynatan Chewable Pediatric Tablets: Children over six years of age 1 to 2 chewable tablets; Children two to six years of age 1/2 or 1 chewable tablet. How Supplied Rynatan Chewable Pediatric Tablets (phenylephrine tannate 5 mg, and chlorpheniramine tannate 4.5 mg): purple-colored, caplet-shaped, scored on one side and imprinted RYNATAN 712 on the other side. The chewable tablets are available in bottles of 30 (NDC 0037-0712-03). Storage: Store at controlled room temperature 20 - 25 C (68 - 77 F). Dispense in a tight container. Protect from moisture. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Produced under license from JFC Technologies Bound Brook, NJ, U.S.A. U.S. Patents 5,599,846; 5,663,415 MEDA Pharmaceuticals Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 Printed in U.S.A. Rev. 1/09 Package Label - Principal Display Panel 30 Tablet Bottle NDC 0037-0712-03 RYNATAN CHEWABLE Pediatric Tablets (phenylephrine tannate, chlorpheniramine tannate) 30 Tablets Each tablet contains: Phenylephrine Tannate, 5 mg Chlorpheniramine Tannate, 4.5 mg Rx only MEDA Pharmaceuticals Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 LB-071203-05 Rev. 1/09 Usual Dose: See package insert. Store at controlled room temperature 20 -25 C (68 -77 F). Dispense in a tight container. Protect from moisture. Produced under license from JFC Technologies Bound Brook, NJ, U.S.A. U.S. Patents 5,599,846; 5,663,415 RYNATAN CHEWABLE PEDIATRIC phenylephrine tannate and chlorpheniramine tannate tablet Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-0712 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE TANNATE (PHENYLEPHRINE) PHENYLEPHRINE TANNATE 5 mg CHLORPHENIRAMINE TANNATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE TANNATE 4.5 mg Product Characteristics Color PURPLE Score 2 pieces Shape CAPSULE Size 15mm Flavor GRAPE Imprint Code RYNATAN;712 Contains Packaging # Item Code Package Description 1 NDC:0037-0712-03 30 TABLET (30 TABLET) in 1 BOTTLE 2 NDC:0037-0712-12 10 PACKET (PACKET) in 1 BOX 2 2 POUCH (POUCH) in 1 PACKET 2 1 TABLET (2 TABLET) in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 10/24/2005 09/30/2012 Labeler - Meda Pharmaceuticals Inc. (051229602) Revised: 06/2011 Meda Pharmaceuticals Inc. Next Interactions Print this page Add to My Med List More about Rynatan Pediatric (chlorpheniramine / phenylephrine) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: upper respiratory combinations Consumer resources Professional resources Rynatan Pediatric Suspension (FDA) Other brands: AccuHist Drops , R-Tanna , Sildec-PE , Sonahist Other Formulations Rynatan Related treatment guides Allergic Rhinitis Cold Symptoms FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug WADA Class Anti-Doping Classification Drug Class Upper respiratory combinations Related Drugs upper respiratory combinations Promethazine DM , Cheratussin AC , Mucinex DM Cold Symptoms diphenhydramine , Benadryl , Promethazine DM , chlorpheniramine , echinacea , Tussionex Pennkinetic , Banophen , Benadryl Allergy , Chlor-Trimeton , Guaifenex , Triaminic , Promethazine with Dextromethorphan , More... 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